The field of the invention is container labeling and more specifically labeling systems ensure that machine readable labels or devices correspond to human readable labels or the like.
With the widespread acceptance of electronic processors and machine-readable memories or labels, interactive electronic devices that can actually read information from memories and labels are becoming extremely common. For example, simple bar codes have been used for many years on grocery products to indicate the product type. In this case, upon checking out of a grocery store products are passed over a bar code reader which reads the bar code information to identify the product, correlates the product with a cost and adds the cost to a running cost total to be paid by a customer.
In addition to increasing efficiency, simple bar codes are advantageous because they are extremely inexpensive to produce. For example, simple bar codes are typically printed directly on an observable surface or on a label that is then attached to a container or other item identifying device (e.g., a wristband). Moreover, simple bar codes are usually used only to provide minimal information and therefore code-reading devices need not be very complex.
While simple bar codes have several advantages, unfortunately such simple codes have two important shortcomings. First, two limitations taken together restrict the amount of information that can be stored using a simple bar code. To this end, bar codes are relatively unattractive and therefore only small areas are reserved on package exterior surfaces to accommodate such codes. In addition, in order to be read using conventional bar code readers, code bars have to be at least a certain size. Thus, minimum bar size and maximum code area together limit the maximum amount of information storable via a simple bar code. For example, a typical simple code on a cereal box may only indicate cereal type and box volume (i.e., cereal quantity in the box).
Second, because of how bar codes are typically used, bar coded information is often limited to independently authenticatable and confirmable information types. For example, the end result of relying upon a cereal box bar code when checking out at a grocery store is to pay a specific price for the cereal within the box. For this reason it is important that, after a bar code is read, a consumer can independently compare the bar code information to known information. In the case of the cereal box this means that the consumer can compare the information read from the bar code to other information provided on the exterior surfaces of the cereal box to confirm that the information is consistent. Thus, the code and human readable information is redundant and comparable.
As another example, patient wristbands at medical facilities often include bar codes that can be used with a bar code reader to identify patients. In these cases the code readable patient identification can be independently legitimized and corroborated by asking a conscious and cognizant patient to confirm that the patient is in fact the patient identified by the band. Thus, the coded information and the known identity of the patient are redundant and comparable.
These two limitations combine to render simple bar codes essentially useless for some applications. For example, U.S. Pat. No. 5,852,590 titled “Interactive Label for Medication Containers and Dispensers” that was issued on Dec. 22, 1998 teaches several different embodiments of memory devices attached to external surfaces of medication containers where the devices are capable of storing a relatively larger amount of information when compared to simple bar codes. The memory devices may be, for example, relatively more complex multi-dimensional (e.g., two or three-dimensional) bar codes or dot matrices or RFID tags.
The above referenced application teaches that various types of redundant (i.e., information repeated in a human readable form on the container) and unique (i.e., information that is not repeated in human readable form on the container) information related to the medication to be stored in the containers can be stored on the memory devices. For example, a prescribing physician's identification, a primary physician's identification, a consumption regimen, contra-indication information, allergy information, re-ordering information, e-mail addresses of a primary physician and/or a prescribing physician, identification of the person to take the medication, patient physical characteristics, medication manufacturer's information, consumption rescheduling information, instructions for notifying a primary physician of a prescription, processor instructions for post-consumption queries regarding symptoms and instructions for functions to perform when specific symptoms occur, etc., can all be stored in the memory device.
The above referenced application also teaches processing devices that cooperate with the memory devices to facilitate various health related functions. For example, one health related function is to alert a device user whenever a prescription calls for medication consumption. Another function is to, when medication is removed from a container, update a quantity representative of the amount of medication in the container. One other function is to, when the quantity falls to a specified level and a medication can be refilled, automatically order the refill medication via a computer network (i.e., the Internet) or the like. Yet another function is to track mis-medication (i.e., when a medication was supposed to be consumed but was not or when a medication was consumed at a time that was not prescribed) and either notify the device user or a physician or indicate such mis-medication via a compiled report. Thus, clearly additional memory capabilities facilitate many useful and valuable functions.
While the present invention can be used in any of several different applications, in the interest of simplifying this explanation, the prior art and the present invention will be described in the context of the medical prescribing and pharmaceutical industry generally unless specifically indicated otherwise.
Unfortunately, as is often the case, additional functionality comes at a price. First, memory device readers constitute an added medication cost and therefore, while there are many advantages associated with such devices, some medication users will not be able to afford such memory readers. In addition, even if a medication user can afford a reader device, many users may not want the functionality that is facilitated by such readers. Indifference to such functionality will be particularly acute where a person only sporadically uses medication as in the case of a typical healthy adult. In either of these cases, the medication users will not have memory readers.
Second, in many cases the enhanced memory devices are relatively more expensive than simple bar codes. For example, an RFID tag includes a small processor, an electronic memory and a printed antenna, all of the components provided on a label or printed directly on the surface of a container. Multi-dimensional bar codes and dot matrices are sometimes subject to licensing fees and therefore are also relatively expensive. Thus, to minimize overall medication costs, enhanced memory devices should only be used in cases where a medication user has and employs a memory reader.
Third and, perhaps most importantly, as indicated above, much of the information that is useful to facilitate the additional functionality will not be redundant but instead will be unique and, for this reason there will be no way for a medication user to independently confirm that the information required to support intended functionality is actually provided on the memory device or, if provided, is correct. For example, a primary physician's e-mail address and notification instructions for warning the physician that a particular medication has been prescribed for a patient typically will not be provided in human readable form and therefore that information cannot be independently verified by a system user.
As another example, it may be the case that, with a specific medication, if dizziness occurs one hour after consumption, the prescription should be altered and/or an e-mail should be transmitted to the prescribing physician notifying the physician of the symptom. In this case, the memory information may include a query regarding dizziness, instructions to provide the query one hour after consumption, instructions to alter the prescription and/or transmit an e-mail to the physician if dizziness occurs and the physician's e-mail address. All of this information is important but nevertheless cannot be independently confirmed by a system user as the information would not be provided in a human readable format.
It might also be noted that even if such a laundry list of information were provided in a human readable format it is likely no one would take the time to compare the memory stored information and the human readable information to make sure that the information matched and was accurate.
While independent confirmation of information stored on an enhanced memory device is essentially impossible after a patient leaves a medical facility, unfortunately, negative consequences can result from incorrect information. For example, if a regimen prescribed for patient A is different than a regimen prescribed for patient B and patient A's regimen information is stored on a memory device attached to a medication container marked in human readable form for patient B, patient B will be alerted to take the medication in the container at incorrect consumption times (assuming the regimen's for patients A and B are different). As another example, if patient A's physician is notified of mis-medication instead of patient B's physician due to incorrect information on a memory device, the physician may either not recognize the patient identified in the message and therefore ignore the notice or may assume that an emergency has occurred. Many other sequences of inadvertent and problematic events are contemplated.
Fourth; the task of writing information to enhanced devices would be an additional burden. To this end, it is contemplated that the device readers will be programmable to perform many different functions and the different functions may require different information and that, for each medication there may be different information required to be written to the enhanced devices. Specifying all of this information each time a medication is to be dispensed would be extremely time consuming.
Fifth, even if the costs associated with enhanced devices are reduced to the point where such devices can be included on every container despite some container users not having reader devices, there will always be the problem of making sure that, for users of reader devices, information is provided on the enhanced devices. For example, assume a medication user does have a reader device and therefore wants to have a vial having an enhanced device that can be used by the reader to support certain functions. When a pharmacist dispenses medication to vial, labels the vial for the user and writes information to the enhanced device, there is no way to ensure that information intended for the enhanced device was actually written thereto. To an observer a vial with printed indicia will appear as a completely specified vial.
Thus, it would be advantageous to have a labeling system that could automatically determine when an enhanced memory device is desired for a medication container and that provides a container with such a device. In addition, it would be advantageous to have a system wherein a computer automatically confirms that the information on a machine-readable memory device is related to the printed and human readable information on a corresponding container.